Percutaneous dilational device

ABSTRACT

A dilator ( 10 ) for creating tracheostomies in one pass. Dilator ( 10 ) includes a generally linear shaft ( 12 ) extending from a proximal end ( 14 ) and beginning at a distance therefrom, gradually and continuously through a curved distal portion ( 16 ) of continuously decreasing diameter (from about 38 french) to a distal tip portion ( 18 ) of small diameter of about 12 french at distal end ( 20 ). The outer surface of the insertable portion is treated or hydrophilically coated to minimize friction, and the gradual taper gradually widens the tracheal entrance opening ( 44 ) between tracheal rings ( 46,48 ) with minimal trauma. The wall thickness gradually decreases from the linear shaft ( 12 ) to the soft distal tip portion ( 18 ). The continuing curve of the distal portion ( 16 ) enables the increasingly longer inserted portion of the dilator to remain situated in the trachea ( 50 ) during insertion and for the distal tip portion to clear the posterior tracheal wall.

RELATED APPLICATION INFORMATION

[0001] This application claims priority of Provisional ApplicationSerial No. 60/169,368 filed Dec. 7, 1999.

TECHNICAL FIELD

[0002] This relates to the field of medical devices and moreparticularly to devices for percutaneous dilation.

BACKGROUND OF THE INVENTION

[0003] Certain medical devices are known that are used in the atraumaticdilation into a patient, such as percutaneously accessing a patient'sair passageway and dilating an opening thereto, and forming an ostomy inthe tracheal wall. A tracheal tube is then inserted through the ostomyand into the trachea to establish a passageway for unobstructed airflow. To minimize trauma to the patient, it has been found desirable toinitially incise only a small opening as an entrance, and thereafter toenlarge the opening with further dilation.

[0004] Sold by Cook Critical Care, Division of Cook Inc., Ellettsville,Ind., is the “Ciaglia Percutaneous Tracheostomy Introducer Set”, usedfor controlled percutaneous introduction of tracheostomy tubes.Sequentially sized dilators (from 12 french to 38 french) are advancedover a wire guide/guiding catheter system to facilitate gradual dilationof the tracheal entrance site to an appropriate size; one such dilatoris shown in FIG. 1 and herein below described. The tracheostomy tube isplaced by fitting the tube over the appropriate size dilator andadvancing the tube into position. Each of the dilators includes anelongated linear shaft for manual gripping and manipulation, and isprovided with a curved distal end concluding in a tapered tip that inuse is coated with lubricating jelly, all to minimize trauma. First, thesmallest dilator (12 french outer diameter) is first selected and placedover a guiding catheter and guide wire that extend through the openinguntil the tip is adjacent to the opening. Then the tapered tip is urgedgently into the percutaneous incision and between adjacent ones of thetrachea rings, and is gently withdrawn and reinserted to gradually widenthe opening. The first dilator is then withdrawn and removed, andreplaced by the next larger sized dilator and the procedure is repeateduntil the appropriate sized ostomy has been created.

[0005] It is desired to simplify the procedure used to create the ostomyand to shorten the length of time involved in its creation.

SUMMARY OF THE INVENTION

[0006] The present invention is directed toward a single dilator that isused to define the ostomy in one pass, thus replacing the severalsequentially sized dilators and eliminating the repeated changingthereof, and thereby greatly simplifying the procedure and substantiallyshorten the time to define the ostomy, all serving to minimize patienttrauma. The single dilator includes a soft, pliant tapered tip identicalin shape and size and in tip inner diameter to those of the prior artdilators, and additionally includes a curved distal portion extendingfrom the tapered tip toward the proximal end, and the generally linearshaft. The curved distal portion is tapered to extend from a diameter of12 french (for example) adjacent the tapered tip, to a diameter of 38french adjacent the linear shaft. Preferably both the curvature and thetaper of the curved tapered distal portion from the distal tip to theshaft is gradual with no discontinuities. Also preferably, the curvedtapered distal portion has a gradual transition in flexibility from veryflexible at the short distal tip portion to generally rigid at thegenerally linear shaft portion, such as by gradually changing its wallthickness.

[0007] The resultant shape of the dilator of the present invention canbe said to resemble the horn of a rhinoceros. Particularly useful fortracheostomies, the continuing curve of the distal end portion enablesthe increasingly longer inserted portion of the dilator to be situatedin the trachea thus facilitating clearing the posterior tracheal wall.

[0008] Preferably the curved tapered distal portion and the short distaltip portion are provided with a hydrophilic coating that obviates theneed for lubricating jelly and provides a very low coefficient offriction when hydrated, thus facilitating insertion into and withdrawalfrom the tracheal opening.

[0009] An embodiment of the invention will now be described by way ofexample with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0010]FIG. 1 is an elevation view of a Prior Art dilator;

[0011]FIGS. 2 and 3 are elevational and longitudinal section views ofthe dilator of the present invention; and

[0012]FIG. 4 is an elevation view of the dilator in position over aguide wire and extending through an entrance to a trachea.

DETAILED DESCRIPTION

[0013] Dilator 100 of FIG. 1 is a Prior Art dilator, namely, one of aseries of dilators found in the “Ciaglia Percutaneous TracheostomyIntroducer Set” sold by Cook Critical Care, Division of Cook Inc.,Ellettsville, Ind., used for controlled percutaneous introduction oftracheostomy tubes and having sequentially sized dilators (from 12french to 38 french). Dilator 100 in particular is the largest of theseries used last in the sequence to attain a tracheal entrance of about38 french. Dilator 100 includes a shaft portion 112 extending from aproximal end 114, a tip portion 118 adjacent to distal end 120, and acurved intermediate section 130 extending between shaft portion 112 andtip portion 118. An insertion depth marking 122 is defined a distance ofabout 50 mm (2.0 in) from distal end 120, and on dilator 100 ispositioned midway along curved intermediate section 130. A centralpassageway 124 extends from proximal end 114 to distal end 120.

[0014] Tip portion 118 on Prior Art dilator 100 is about 20.0 mm (0.79in) in length and has a taper along each side of about 0.223 mm per mm(0.223 in per in), or about 12.6 degrees. (On smaller dilators of the“Introducer Set” the length of tip portion 118 is shorter while thetaper remains the same; the insertion depth marking 122 may be along thelinear shaft portion 112 on the smaller dilators.) Curvature of thecenterline of curved intermediate section 130 is a radius R of about 80mm (3.15 in) over an angular distance θ of about 20° to 40°. Wallthickness immediately at the distal end 120 is about 0.406 mm (0.016in), and thickens over the portion extending for 5.99 mm (0.236 in.)from distal end 120 to a thickness of about 1.09 mm (0.043 in), which isthe wall thickness of curved intermediate section 130 and the shaftportion 112, and at proximal end 114.

[0015] In Prior Art dilator 100, the outer diameter from the locationfrom tip portion 118 is constant to proximal end 114 and is 38 french or12.7 mm (0.491 in). Also, the wall thickness between tip portion 118 andproximal end 114 is constant at 1.09 mm (0.043 in). The durometer ismeasured at about 55 to 60 Shore D hardness.

[0016] Dilator 10 of the present invention is shown in FIGS. 2 to 4 andincludes a shaft portion 12 extending from a proximal end 14, and acurved tapered distal portion 16 extending from shaft portion 12 to asmall tip portion 18 at distal end 20. Demarcation 22 denotes thelocation at which the outer diameter is 38 french. A central passageway24 extends completely there through from proximal end 14 to distal end20. A marking 26 is identified toward proximal end 14 from demarcation22 that indicates the recommended depth of maximum insertion into theskin, and that is at that location at which the shaft portion 12 and thecurved tapered distal portion 16 meet.

[0017] Preferred dimensions of dilator 10 for use especially intracheostomy procedures are: an overall length of about 196 to 210 mm(7.75 to 8.25 in); a length of about 110 mm (4.33 in) from distal end 18to insertion depth marking 26; an inner diameter at distal end 20 ofabout 2.79 mm (0.110 in) and that extends the short length of flexibletip portion 18, about 3.18 mm (0.125 in); an outer diameter at distalend 18 of about 12 french or 4 mm (0.140 in); and an outer diameter atproximal end 14 of about 50 french or 16.5 mm (0.650 in), with an innerdiameter of about 12.0 mm (0.473 in). The outer diameter at demarcation22, as mentioned above, is about 38 french or 12.7 mm (0.491 in) and islocated at about a distance of 80 mm (3.150 in) from distal end 20; andthe inner diameter at demarcation 22 is about 7.72 mm (0.304 in).

[0018] The taper of the curved tapered distal portion 16 of the exampledescribed is about 0.056 mm per mm, or 3.19°. The taper may be within arange of tapers of between 1.7° and 10°. A very gradual taper such asabout 1°00′ may also, if desired, be used for the shaft portion 12 forfacilitating removal of the molded dilator from the molding apparatus.Continuation of the taper in the proximal direction from curved tapereddistal portion 16 also serves to permit, if necessary, further wideningof the ostomy beyond 38 french, such as to 40.5 french at the insertionlimit 26.

[0019] The curvature of curved tapered distal portion 16 may be a seriesof curves of different radii, or a complex curve, from distal end 20 atleast to demarcation 22. The portion of dilator 10 between demarcation22 and insertion limit 26 will extend, during use of the dilator,between the outer skin of the patient and the inside or anterior surfaceof the trachea of the patient. Also, the optimum curvature may be withina range such that the outer surfaces are within a zone of tolerance.While not susceptible of a precise mathematic definition, it ispreferred that the curvature be complementary to the curvature ofconventional curved tracheostomy tubes.

[0020] Preferably, the curved distal portion 16 transitions graduallyfrom a very flexible short tip portion 18 at distal end 20, to a morerigid shaft 12 at insertion limit 26, thus having increasing rigidity inthe direction extending away from distal end 20. Such flexibilitytransition may be generated such as providing a very small wallthickness at distal end 18 (e.g., 0.381 mm or 0.015 in) and greater wallthickness along shaft 12 of about 2.49 mm (0.098 in). Shaft 12 may alsohave a gradual taper, if desired. Dilator 10 may be made frompolyurethane and be of softer durometer than prior art dilators, such asa durometer of about 43 Shore D hardness. Fabrication may beaccomplished such as by molding the dilator initially in a lineartapered shape with appropriate wall thicknesses, and then insertingthrough the central passageway a rigid forming wire of stainless steelhaving an appropriate curved shape to elastically deform the dilatorfrom its initial linear shape to generate the desired curve of theintermediate portion, and then post-curing the dilator at elevatedtemperatures with the forming wire in place, whereafter the dilatorretains an appropriately curved shape. Sharp edges at the proximal endmay be removed by abrasion, and the edges of the tip at distal end 20may be rounded by careful application of localized heating and pressureto remove sharp edges.

[0021] Preferably, dilator 10 has a hydrophilic coating along curvedtapered end portion 16 such as PHOTO-LINK coating material commerciallyavailable from SurModics, Inc., Eden Prairie, Minn. The material is aliquid mixture of PV05 Photo-Polyvinylpyrrolidone copolymer, PA05Photo-Polyacrylamide copolymer, 2-propanol and distilled water. Upon theintermediate and distal end portions of the dilator being dipped into abath of the mixture, with the distal end being occluded to isolate theinterior surfaces, the coating on the dilator is cured by ultravioletlight at 150 wpi. Dilator 10 is preferably of radiopaque material, andit may be blue in color to minimize glare when viewed by an endotrachealbronchoscope that is in position in the patient above the tracheal ring46 to view the procedure within the trachea from above the trachealentrance.

[0022]FIG. 4 illustrates the use of dilator 10 positioned on and along aguide wire 40 that extends through incision 42 of a patient and intracheal entrance 44 between adjacent tracheal rings 46,48, to introducea tracheostomy tube (not shown) into trachea 50. Guide wire 40 includesa flexible J-shaped tip 52 and a guiding catheter 54 of 8.0 french overmuch of the guide wire. Guiding catheter 54 preferably includes anannular protrusion 56 there around to act as a stop for the distal end20 of dilator 10. Dilator 10 is inserted over guide wire 40 until distalend 20 abuts annular protrusion 56.

[0023] With the curved tapered distal portion 16 hydrated such as bybeing dipped into sterile saline or water to hydrate and thus activatethe hydrophilic coating thereon, dilator 10 is moved along guidingcatheter 54 and the distal tip portion of dilator 10 is inserted intotracheal entrance opening. The assembly is then gently urged repeatedlyinto and partially withdrawn from the tracheal entrance opening 44 andprying apart tracheal rings 46,48 in an iterative procedure, increasingthe insertion depth gradually each time until tracheal entrance opening44 has been made sufficiently wide to enable a tracheostomy tube ofappropriate size to be inserted there through. Once hydrated by beingimmersed into sterile saline or water, the outer surface of curvedtapered distal portion is made very slippery without the use oflubricating jelly, with a substantially lowered coefficient of frictionto minimize trauma to the patient. Marking 26 indicates the safety limitof insertion of the dilator into the patient's incision 42.

[0024] Dilator 10 is then removed from guide wire 40, and a loadingdilator (not shown) of appropriate size is placed thereon, with thetracheostomy tube already placed on the loading dilator, extendingthrough the widened tracheal entrance opening. Such a loading dilatormay be similar to one of the larger Prior Art dilators as shown inFIG. 1. Thereafter, procedures are followed as with the prior art“Ciaglia Percutaneous Tracheostomy Introducer Set” instructions; thetracheostomy tube is translated along the loading dilator until fullyinserted into the patient.

[0025] The dilator of the present invention results in a simplifiedprocedure with fewer steps and shortens procedure time.

What is claimed is:
 1. A dilator for tracheostomies, comprising: amember extending from a proximal end to a distal end with a passagewayextending therethrough defined by a wall, the member having an elongategenerally linear shaft portion extending from the proximal end andhaving a large diameter, a small diameter short distal tip portionadjacent the distal end, and a curved tapered distal portion extendingfrom the generally linear shaft portion to the short distal tip portion.2. The dilator of claim 1, wherein the curvature and the tapering of thecurved tapered distal portion is gradual and continuous.
 3. The dilatorof claim 1, wherein the wall thickness of at least the curved tapereddistal portion decreases from the generally linear shaft portion to theshort distal tip portion.
 4. The dilator of claim 1, wherein at leastthe curved tapered distal portion has an outer surface that islubricious.
 5. The dilator of claim 4, wherein the outer surface iscoated with hydrophilic material.
 6. The dilator of claim 1, wherein thetaper of the curved tapered distal portion is within a range of about1.7° to about 10°.
 7. The dilator of claim 6, wherein the taper is about3.19°.
 8. The dilator of claim 1, wherein the generally linear shaftportion has a taper of about 1°.
 9. The dilator of claim 1, wherein theproximal end has an outer diameter of about 50 french.
 10. The dilatorof claim 1, wherein the distal end has an outer diameter of about 12french.
 11. The dilator of claim 1, wherein the short distal tip portionhas a constant inner diameter and a tapered outer diameter.
 12. Thedilator of claim 11, wherein the short distal tip portion is veryflexible and the generally linear shaft portion is generally rigid. 13.The dilator of claim 12, wherein the curved tapered distal portion has agradual transition in its flexibility from very flexible at the shortdistal tip portion to generally rigid at the generally linear shaftportion.
 14. The dilator of claim 1, wherein a marking is provided onthe outer surface of the member between the generally linear shaftportion and the curved tapered distal portion to indicate the safetylimit of insertion into the incision.
 15. The dilator of claim 1,wherein a demarcation is provided on the outer surface of the curvedtapered distal portion to indicate the outer diameter at thedemarcation.
 16. A dilator for tracheostomies, comprising: a memberextending from a proximal end to a distal end with a passagewayextending therethrough defined by a wall, the member having an elongategenerally linear shaft portion extending from the proximal end andhaving a large diameter, a small diameter short distal tip portionadjacent the distal end, and a curved tapered distal portion extendingfrom the generally linear shaft portion to the short distal tip portion;the curvature and the tapering of the curved tapered distal portion isgradual and continuous; the wall thickness of at least the curvedtapered distal portion decreases from the generally linear shaft portionto the short distal tip portion; the curved tapered distal portion hasan outer surface that is lubricious; the taper of the curved tapereddistal portion is about 3.19°; the short distal tip portion is veryflexible and the generally linear shaft portion is generally rigid andthe curved tapered distal portion has a gradual transition in itsflexibility from very flexible at the short distal tip portion togenerally rigid at the generally linear shaft portion; and a marking isprovided on the outer surface of the member between the generally linearshaft portion and the curved tapered distal portion to indicate thesafety limit of insertion into the incision.